1. Field of the Invention
This invention relates generally to a voice prosthesis. More specifically, this invention relates to a tracheal-esophageal voice prosthesis device which allows post-laryngectomy patients having a surgically created tracheostoma and a tracheal-esophageal fistula to produce nearly effortless speech as near to normal as possible.
2. Discussion of Related and Prior Art
The human larynx is susceptible to injury, trauma and various types of diseases such as cancer. It has been known for over 100 years that sounds can be made without the use of the larynx. After removal of the larynx, the patient is known as an laryngectomee and is left with the following three options available for regaining speech:
Electrolarynx Speech--Wherein the laryngectomee uses a electronic device which produces a generally monotonal output modulated by the vibrations received from a transducer held to the outside of the throat or one which has a tubing placed inside the mouth to produce sounds. This type of speech is easy to learn, but has a rather mechanical sound and the unit must be turned on during speaking and also requires the use of one hand to hold the device. Electrolarynx speech has been judged as the least acceptable of the three types of speech. PA1 Esophageal Speech--Wherein the laryngectomee must periodically swallow quantities of air and to speak, release the air by regurgitating or burping to allow the air to travel up the esophagus causing the membranes to vibrate sounds and with the aid of the tongue, teeth, and nasal passages, etc., to create speech through the mouth. Esophageal speech is the most difficult of the three types to learn with a success range from 25% to 90%, and in most cases, requires many weeks of expensive voice lessons to master the technique. Esophageal speech has been judged superior to electrolarynx speech. PA1 Tracheal-Esophageal Speech--Wherein the laryngectomee having a surgically created tracheostoma and a tracheal-esophageal fistula uses a voice prosthesis device that is placed in the trachea and inserted through a tracheal-esophageal fistula into the esophagus. Tracheal-esophageal speech occurs when a finger, thumb, or tracheostoma valve covers the stoma opening outside the neck to divert the exhaled air from the lungs to the trachea and through the prosthesis device into the esophagus while at the same time preventing the esophageal material from entering into the trachea, then the exhaled air travels up the esophagus causing the membranes to vibrate sounds and with the aid of the tongue, teeth, and nasal passages, etc., to create speech through the mouth. Tracheal-esophageal speech is nearer to normal speech and has been judged significantly superior to electrolarynx and esophageal speech.
In order to provide background information so that the invention may be completely understood and appreciated in its proper context, reference now may be made to a number of prior art patents, and publications as follows:
In the past, artificial larynx devices and voice prostheses have been built to accomodate various positions inside and outside the neck. Some of the earlier types housed different types of reed valves and vibrating devices in an effort to reproduce the function of the larynx. Many of these devices were incapable of functioning properly due to saliva drainage from the mouth into the devices, aspiration of esophageal material into the trachea, leakage of the various valves and the valve flapper would herniate beyond the valve seat to mention only a few of the many problems which occurred.
The Henley-Cohn et al. U.S. Pat. No. 4,439,872; Pruitt U.S. Pat. No. 4,596,579; and the Panje U.S. Pat. No. 4,808,183; each illustrate a prosthesis having a rearward end duckbill type valve that extends deeply into the esophagus. Consequently, the rearward end of the duckbill prosthesis at times comes in contact with the rearward wall of the esophagus, thus restricting the air flowing up the esophagus and with its' long extended end within the esophagus, it further impedes the ability to speak; swallowing of food and pills; or drinking liquids. Duckbill prostheses generally have a smaller tubing bore size which minimizes the volume of air flow into the esophagus. Valve leakage of the duckbill type prostheses also occurs more often than with other prostheses.
U.S. Pat. No. 4,435,853 to Blom et al.; U.S. Pat. No. 4,610,691 to Depel et al.; U.S. Pat. No. 4,614,516 to Blom et al.; and U.S. Pat. No. 4,820,304 to Depel et al.; all have a protective hood over the valve or a circumferential extending shoulder which also extends deeply into the esophagus, and like the aforementioned duckbill types, also impede the ability to speak; swallowing of food and pills; or drinking liquids with the extended shoulder of foreign material in the esophagus. The above mentioned prostheses have a one-way valve formed as part of the tubular housing of the prosthesis or one that is cemented within the housing that is non-changeable when valve leakage occurs. All of the past prostheses can be worn for only a few weeks until the one-way valve begins to leak esophageal material into the trachea. Then, the entire prosthesis must be thrown away and a new one installed which is an added expense to the laryngectomee.
U.S. Pat. No. 4,911,716 to Blom et al.; in particular, discloses a surgical implant for use with a voice prosthesis. This implant is left secured to both sides of the tracheal-esophageal fistula and the tubular housing of the prosthesis device is the only part that the wearer can remove to clean or replace when the valve begins to leak. If the implant is left for long periods of time in the patient and an inflamed wall or growth of cancer did occur around the implant, it may go undetected in the fistula since the implant covers this area. The wearer is also restricted in that the implant may be removed only by trained personnel at the hospital or at their office which is also an added expense to the wearer.
Further, many tubular housing prostheses are made from silicone materials that have been found to become contaminated with food particles, mucus, saliva, and certain species of Candida or flora that occasionally infect mucus membranes of the throat and trachea areas. See, Mahieu, H. F., et al., "Candida Vegetations on Silicone Voice Prostheses," Arch. Otolaryngol. Head Neck Surg., Mar. 1986, Vol. 112, pp. 321-325.
Heretofore, voice prostheses have been produced in commercial quantities, with the laryngectomee having a limited selection of only a few types and sizes to fit all. Herein lies the problem, in the same way people require different eye prescriptions or teeth replacement and the like, so should the voice prosthesis be fitted for each individual laryngectomee. Each laryngectomee should be fitted correctly to achieve the best possible vocalization with the least amount of strain or effort to produce speech.
Whatever the precise merits, features and advantages of the above cited references, none of them achieves or fulfills the purposes of the current tracheoesophageal voice prosthesis and insertion tool of the present invention.